Strides Arcolab gets USFDA warning letter

Written by Press Trust of India | New Delhi | Updated: Sep 17 2013, 03:40am hrs
Drug firm Strides Arcolab today said the US health regulator has issued a warning letter against a manufacturing facility of its subsidiary Agila Specialties.

"The sterile manufacturing facility 2 (SFF) at Bangalore of Agila Specialties Pvt Ltd, a wholly owned subsidiary of the company, has received a warning letter from the United States Food and Drug Administration (USFDA)," Strides Arcolab said in a filing to the BSE.

"The company is committed to work collaboratively and expeditiously with the USFDA to resolve concerns cited in the warning letter in the shortest possible time," it added.

USFDA had inspected SFF in the month of June 2013 and the inspection resulted in issuance of 'Form FDA 483' with observations. Strides had responded to the 483 observations by implementing corrective actions, it said.

Meanwhile, the company said the USFDA has cleared the oncology facility at Bangalore of Agila Specialties, which was also inspected recently by the US FDA .

"This facility has cleared the inspection with "Zero 483 status," Strides said.

The Bangalore-based firm has eight USFDA approved sterile manufacturing facilities. Share of the company closed at Rs 869.10 on the BSE, down 3.45 per cent from its previous close.